Syringe Devices, Components of Syringe Devices, and Methods of Forming Components and Syringe Devices

ABSTRACT

A syringe device includes a syringe barrel and piston having a fluid passageway extending from a vial port. Another syringe device includes a syringe barrel, a piston sleeve and an insert. A channel extends along a side of the insert. A valve controls fluid communication between the channel and the syringe barrel. Another syringe device has a syringe barrel, a piston sleeve and an insert. A valve controls fluid communication between a compartment within the insert and the syringe barrel. A method of preparing a medication includes providing a component within a syringe barrel and another component within a compartment of a piston insert. A seal is over-molded onto a tip of the insert and an end of a piston sleeve. The sleeve is rotated relative to the insert to establish fluid communication between the compartment and the barrel chamber.

RELATED PATENT DATA

This patent claims priority under 35 U.S.C. § 119 to U.S. ProvisionalApplication No. 60/735,481, which was filed Nov. 9, 2005; and claimspriority to U.S. Provisional Application No. 60/763,647, which was filedJan. 30, 2006.

TECHNICAL FIELD

Embodiments of the invention pertain to syringe devices, syringe pistonconfigurations, medication agent preparation systems and methods ofpreparing a medication agent.

BACKGROUND OF THE INVENTION

Preparation of medicants or medication agents and administration of suchagents to an individual often involves mixing of two or more componentsto form the agent and subsequent delivery of the mixed medicant to theindividual. The mixing of components can typically involve extraction ofone component in fluid form from a vial or other container and transferof such components into a separate container which holds anothercomponent. In particular instances, only a portion of the contents of avial or container is to be utilized for preparing a mixture prior toadministering. Accordingly, the extraction and transfer can involveprecise measuring of one or more components to be mixed.

A variety of problems may occur when utilizing conventional methodologyand devices for mixing and/or administering medicants to an individual.For example, where multiple components are to be mixed, extraction andtransfer of one component and introduction of such component intoanother component can potentially expose one or both of the componentsto a non-sterile or contaminated environment leading to contamination ofthe resulting medicant. Additionally, incomplete extraction or impropermeasurement of one or more components can result in preparation and/oradministration of an improper dosage. In particular instances, once amedicant is mixed the mixture must again be extracted from a vial orcontainer into a syringe prior to administering to an individual. Suchadditional transfer can lead to additional opportunities forcontamination, incomplete extraction of contents and/or inaccuratemeasuring of a component or the resulting medicant.

In practice, there is limited availability of sterile environments formaintaining sterility during transfer and/or mixing of components, orpreparation and transfer of medicants. Additional errors can result fromuse of the wrong diluent to reconstitute the medication. Finally,preparation of medicants utilizing multiple components can be tediousand time consuming due to factors such as the need to accessindividually packaged items such as separate vials and/or transferdevices, or to measure one or more components to be combined to form themedicant.

It would be desirable to develop alternative methodology and systems forpreparation and administration of medicants.

SUMMARY OF THE INVENTION

In one aspect the invention encompasses a syringe device. The deviceincludes a syringe barrel and piston having a first end insertablewithin the syringe barrel. A second end of the piston opposes the firstend and the piston has an overall length defined between the first andsecond ends. A vial port is disposed within the piston and is configuredto receive a vial in lengthwise orientation along a portion of theoverall length of the piston. A fluid passageway extends through thepiston from the vial port through the first end of the piston.

In one aspect the invention encompasses a syringe piston having a stemportion which includes one or more projections. A sealed portion isover-molded onto the stem portion and covers the one or moreprojections.

In another aspect the invention encompasses a syringe device having asyringe barrel and a syringe piston having a first end insertable withinthe syringe barrel and a second end opposing the first end. A vialhousing is associated with and extends from the second end of thepiston. A piercing structure is associated with the second end of thepiston and extends into the vial housing.

In one aspect the invention encompasses a syringe device including asyringe barrel, a piston sleeve and a sleeve insert. The sleeve inserthas a first end insertable within the sleeve and an opposing second end.The sleeve insert has a length defined by the distance between the firstand second ends. A fluid channel extends along an exterior side of thesleeve insert from the first end at least a portion of the length of thesleeve insert. A rotary valve controls fluid communication between thefluid channel and the syringe barrel.

In one aspect the invention encompasses a syringe device having asyringe barrel and a piston sleeve with a sleeve insert having a firstend insertable within the sleeve and an opposing second end with alength of the sleeve insert being defined by the distance between thefirst and second ends. A compartment is disposed within the sleeveinsert and a valve controls fluid communication between the compartmentand the syringe barrel.

In another aspect the invention encompasses a medication agentpreparation system. The system includes a syringe having a syringebarrel with an internal chamber, a piston having a first end, a secondend and a fluid passageway passing longitudinally through the piston, atleast a portion of the piston including the first end being insertedwithin the chamber. A valve is associated with the fluid passageway andincludes a valve body and a cap over-molded onto the valve body.

The invention additionally encompasses a method of preparing amedication agent for administration to an individual. A syringe isprovided having a syringe barrel and a piston disposed at an initialposition relative to the syringe barrel. The piston has a piston sleeveand a sleeve insert. A first component is provided within the syringebarrel and a second component is provided within a vial. A valve isassociated with the fluid passageway between the vial and the barrel ofthe syringe. The valve is initially in a closed position blocking fluidpassage through the passageway. The method includes repositioning thevalve and sliding the piston to join the first and second components.The first and second components are mixed to form a medication agent andthe agent is drawn into the syringe barrel.

In a further aspect the invention includes a method of preparing acomposition including providing a syringe barrel having a barrel chambercontaining a first component and providing a piston having a compartmentcontaining a second component. The piston includes a piston sleeve and asleeve insert. The sleeve insert includes a tip and a body with a sealthat is over-molded onto the tip and an end of the piston sleeve. Theseal has at least one opening passing therethrough. The method includesrotating the piston sleeve relative to the sleeve insert to establishfluid communication between the compartment and the barrel chamber. Thepiston is slid to join the first and second components and the first andsecond components are mixed to form a composition. The composition isdrawn into the syringe chamber.

BRIEF DESCRIPTION OF THE DRAWINGS

Preferred embodiments of the invention are described below withreference to the following accompanying drawings.

FIG. 1 is a side view and partial cross-sectional view of a mixingassembly in accordance with one aspect of the invention.

FIG. 2 is a side view and partial cross-sectional view of a portion of asyringe device in accordance with one aspect of the invention.

FIG. 3A is a side view of a portion of a syringe device with a slidablehousing disposed in a first position.

FIG. 3B is a side view of the portion of the syringe device of FIG. 3Ashown with the slidable housing disposed in a second position.

FIG. 4A is a side view of a mixing assembly in accordance with oneaspect of the invention.

FIG. 4B is an exploded view of the assembly shown in FIG. 4A.

FIG. 5A is an exploded side view of a syringe piston in accordance withone aspect of the invention.

FIG. 5B is an enlarged fragmentary view of the assembled syringe deviceshown in FIG. 5A.

FIG. 5C is a side view of an assembled portion of the syringe pistonshown in FIG. 5A.

FIG. 6 is a side view of a syringe piston in accordance with one aspectof the invention having a tip portion connectable to alternative stemportions.

FIG. 7 is an exploded side view of another syringe piston configurationin accordance with one aspect of the invention.

FIG. 8 is a side view of a piercing device in accordance with one aspectof the invention.

FIG. 9 is a side view of the FIG. 7 piston device in an assembledconfiguration.

FIG. 10 is an exploded side view of an alternative mixing assembly inaccordance with another aspect of the invention.

FIG. 11A is an exploded side view of a portion of the system shown inFIG. 10.

FIG. 11B is an enlarged cross-sectional view of a portion of theassembled form of the system depicted in FIG. 10.

FIG. 12 is a side view of the assembled device shown in FIG. 10 havingalternative features.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

This disclosure of the invention is submitted in furtherance of theconstitutional purposes of the U.S. Patent Laws “to promote the progressof science and useful arts” (Article 1, Section 8).

In general the invention provides methodology and devices for combiningand mixing components to produce a mixture and encompasses deviceconfigurations to allow such combining and mixing to occur withoutcontamination or exposing of the components or mixed agents to anon-sterile environment. In particular, methodology of the inventioninvolves combining and mixing components to produce an administrationready agent such as a medicant and in particular aspects includesadministering such agent to an individual. Accordingly, deviceconfigurations of the invention allow combination of separate componentssuch that the combined and mixed components are administration-ready.The general concepts and example devices in accordance with theinvention are illustrated in the accompanying FIGS. 1-12.

The device components and methods described and exemplified herein canbe utilized in conjunction with, or alternative configurations of, thedevices and methods described in U.S. patent application Ser. No.11/238,880 which was filed Sep. 28, 2005 (henceforth the earlier filedapplication). Accordingly, the specification and figures from suchearlier filed application are hereby incorporated by reference. It is tobe understood that many of the concepts of the present invention can beutilized in conjunction with or can be adapted to other deviceconfigurations including conventional syringe devices and components,those described in the earlier application and those yet to bedeveloped.

Where devices in accordance with the invention are used for preparationof a medicant, the devices are preferably closed-system mixingassemblies. An example of a mixing assembly 10 in accordance with theinvention is illustrated in FIG. 1. Mixing assembly 10 can comprise asyringe body (or barrel) 100 and a piston 200 that has a fluidpassageway longitudinally through a portion of its length (discussedfurther below). In some instances a reversibly attached cap (not shown)may be present providing a fluid seal at a forward end of the syringebody.

Piston 200 has a first end 202 and an opposing second end 204 definingan overall length of the piston. A valve 300 is associated with thefluid channel which passes through a portion of the length of thepiston. A vial port 206 is disposed along a segment of the length of thepiston stem and is configured to receive a vial 500 lengthwise withinthe vial port. Preferably the fluid passageway through the pistonextends from the vial port through first end 202.

Piston 200 further includes a seal 208 which is able to form a slidablefluid tight seal between the internal walls of the syringe body and thesidewalls of the piston seal. Valve 300 can be configured to selectivelycontrol fluid communication between the syringe chamber and vial 500.

Referring to FIG. 2, such illustrates a fluid passageway 220 extendingfrom first end 202 through seal 208 and lengthwise through the piston tovial port 206. A piercing device 400 can be associated with fluidchannel 220 and can extend into port 206. An example piercing device canbe as described in the earlier filed application. Piercing device 400can have a fluid channel passing therethrough and can be configured topuncture the vial septum and be retained across the septum establishingfluid communication between the interior of the vial and fluidpassageway 220.

Vial port 206 can be formed by removal of all or a portion of one ormore piston fins 210. Preferably enough fin structure is retained toallow vial retention and stabilization within port 206.

Valve 300 can be, for example, a two-way valve as illustrated or can bean alternative valve type as described in the earlier filed application.

For the syringe assembly shown in FIGS. 1 and 2, the device ispreferably initially provided in a configuration in which the vial issealed and disposed in a non-contact position relative to piercingstructure 400. In preparation for use the vial can be repositioned tocontact piercing device 400 and slid within the port allowing device 400to puncture and cross the septum. Valve 300 can then be repositioned toan ‘on’ position establishing fluid communication between the vial andthe syringe chamber. Sliding of the piston relative to the syringe canbe utilized to combine syringe contents with vial contents. The twocomponents can be mixed by repeated sliding of the piston or byagitation of the device. The mixed components can then be drawn into thesyringe and the valve closed in preparation for administration of theprepared agent.

Referring to FIG. 3A, an alternative intra-piston vial portconfiguration is illustrated. Features of the illustrated device incommon with the earlier described piston are numbered identically.Features that are additional or different relative to the earlier deviceare denoted by a letter appendage or with a unique numeric identifier.

The illustrated piston 200 has an internal passageway extending fromfirst end 202 to an intra-piston vial port 206 a. The intra-stem vialport is configured to receive a vial housing 510 which can house a vial(not shown). Such vial housing can be insertable through an opening insecond end 204 of the piston. Referring to FIG. 3B, a plurality ofreceiving slots 211 can be configured to guide and position housing 510within the vial port. Piston 200 can comprise a piercing structure (notshown) associated with the vial port and the fluid passageway. Piston200 can preferably be initially provided such that housing 510 and avial received internally within the housing are disposed in anon-contact position such that the piercing device does not contact orpenetrate the vial lid or septum. During preparation for use the vialhousing and internal vial can be slid toward first end 202 to allowpenetration of the vial septum or cap by the piercing device therebyestablishing fluid communication between the interior of the vial andthe fluid passageway of the piston. Fluid passage through the passagewaycan be selectively controlled by valve 300. Preparation of a medicationagent for administration to an individual can be performed by providingan associated syringe (not shown), and utilizing methodology analogousto that described above for the device depicted in FIG. 1.

Another alternative configuration of the invention is described withreference to FIGS. 4A-4B. Referring initially to FIG. 4A, a piston 200is illustrated insertable within a syringe 100 having an internalchamber 102. Syringe piston 200 has an internal passageway passinglongitudinally such that the passageway traverses the length of thepiston. Fluid passage through the passageway is selectively controlledby valve 300 associated with such passageway.

As illustrated, a first end 202 (see FIG. 4B) is inserted within thesyringe barrel and a vial housing 600 is associated with second end 204of the piston. Vial housing 600 can comprise, for example, two parts 602and 604. First part 602 can, in particular instances, be an extension ofpiston 200. Housing part 602 can be integral with, permanently attachedto or reversibly attached to piston 200. A second portion 604 of thevial housing can be configured to be joinable to first portion 602 suchthat a vial inserted within the container can be completely enclosedwithin the housing. Such enclosure of a medicant vial can prevent vialbreakage and can advantageously avoid removal and improper replacementof the vial and/or inadvertent substitution of the vial with anothervial possibly containing an improper diluent or other agent.

Joining of the second part 604 of the housing to the first part of thehousing can comprise, for example, inserting a portion of part 604 intothe first part, inserting a portion of part 602 within part 604,threading of one of the two parts into the other of the two parts,and/or use of other appropriate fittings or joining techniques. Inparticular embodiments, part 604 can preferably be configured to bestabilized in a first position and can be further extended within thesecond part to a second position upon application of force (sliding,twisting or other force based upon the design of the particular fittingconfiguration utilized). Such configuration can allow an enclosed vialto be moved from a first “non-contact” position relative to a piercingdevice (see FIG. 4B) into a second “access” position where the piercingdevice is able to pierce a vial septum or other vial cover and therebyprovide access to vial contents.

In particular implementations the vial housing portion can have anadaptor appendage 606 configured to adapt the syringe device for use inconjunction with a syringe pump. Such appendage can preferably include astem 608 protruding from part 604, where the stem has a first diameter.Stem portion 608 extends to a disk structure 610 where the diskstructure has a diameter greater than the stem structure and isconfigured for insertion into a slot in a piston driver of a syringepump. Such configuration can allow devices in accordance with theinvention to be utilized in a conventional syringe pump. The presence ofthe insertable disk, when inserted into a slot of the piston driver ofthe syringe pump, can prevent inadvertent advancement of the plungerwhen the pump is off. Devices of the invention can alternatively bemanually manipulated.

Referring to FIG. 4B, such shows an exploded view of the device depictedin FIG. 4A. These figures illustrate the association of piercing device400 which can be at second end 204 of piston 200 and can extend intofirst part 602 of the vial housing. FIG. 4B additionally illustrates analternative placement of valve 300 with respect to the overall length ofpiston 200. It is to be understood that the placement of valve 300 alongthe length of the piston is not limited to any particular location andthat the depicted locations are for purposes of illustration only.

As further illustrated in FIG. 4B a seal 208 can be mounted on first end202 of syringe piston 200. Seal 208 preferably has an outer diameteralong at least a portion of its length that forms a fluid seal betweenthe chamber walls and the seal. Where piston 200 comprises an internalfluid passageway, seal 208 can preferably have one or more openings toallow fluid communication between the internal passageway of the pistonand the syringe chamber.

The mixing/administration system 10 depicted in FIGS. 4A-4B caninitially be provided in a “non-contact” position where piercingstructure 400 does not puncture the cap or septum of vial 500. In aparticular configuration, positioning of container parts 602 and 604with respect to one another can be stabilized utilizing a plasticshrink-wrap at least at the junction of the two housing parts. Theshrink-wrap can provide a sterile retainer and prevent inadvertent orunintentional engagement of the piercing device with the vial septum.Positioning can also or alternatively utilize a tack weld or moldedattachment stabilization where a breakable attachment is provided thatcan be broken by application of force (twisting, sliding or other forcedepending upon the particular containment configuration and positioningof the breakable attachment(s)). The two-part container portion of thedescribed syringe device configuration can be formed utilizing materialssuch as plastic materials, preferably hard plastic materials. Spotwelding or tacking can be achieved utilizing, for example, RF welding,microwave welding, heat welding or other appropriate plastic welding.

Another aspect of the invention is described with reference to FIGS.5A-5C. In general, this aspect of the invention involves over-molding ofelastomeric seal portions onto hard plastic body pieces of various partsof devices in accordance with the invention. Over-molding involvesmolding of an overlying part directly onto an underlying supportingpart. It is to be understood that over-molding can be utilized withalternative piston and valve bodies in addition to those specificallydescribed in this particular aspect of the invention. Alternative pistonand valve bodies can include, for example, alternative pistons andvalves described herein, pistons and valves described in the earlierfiled application, conventional pistons and valves and piston, and valveconfigurations yet to be developed.

Referring initially to FIG. 5A, a piston 200 is illustrated having avalve 300 configured to fit into an opening 250, and having a channel220 extending longitudinally through the piston. A piston seal 208 a isillustrated having an opening 219 which extends through the seal.Although FIG. 5A illustrates piston 200 in an exploded view, it is to beunderstood that seal 208 a is permanently attached to the piston duringthe over-molding process.

Piston 200 preferably has at least one projection 223 disposed at ornear first end 202 of the piston. The projection or projections canadvantageously support the over-molded seal and can assist in retainingthe seal on the first end of the piston. Where the piston is configuredto have a fluid passageway or channel passing longitudinallytherethrough, the over-molding process can preferably provide theover-molded seal to have one or more openings extending through the sealto provide fluid communication between the passage through the pistonand the internal region of an associated syringe body.

The over-molding process utilized can be adapted for various syringebody designs such that the over-molded seal has a forward end which isshaped to conform to the taper/shape of the interior of the syringe bodyat the forward end of the syringe body. The seal can preferably bemolded to provide a seal diameter to allow insertion and movement of theseal within the syringe chamber while providing a fluid seal along thechamber sidewalls. In particular aspects, the diameter/size of the sealmold can be modified to produce seals that fit varying syringe barrelsizes without varying the piston size/diameter.

In a similar aspect, valve 300 can comprise a valve body 302 and anover-molded valve cap 310. Valve body 302 can preferably have one ormore projections 304, 306 configured to support and retain theover-molded cap 310.

Valve 300 can be, for example, a push-pull type valve as illustrated inFIG. 5A. In the configuration shown, the push-pull valve body has alarger projection 306 at the inserted end of the valve. The presence ofthe large projection can provide a shape configuration to assist inpositioning and/or retaining the valve within the port when pulling thevalve into an open position. It is to be understood that the inventioncontemplates utilization of alternative valve types such as, forexample, a rotatable valve having an opening passing through the bodyand the over-molded seal.

Valve cap 310 and seal 208 a can comprise, for example, elastomericmaterials. The elastomeric materials utilized can be the same or candiffer from one another. Similarly, piston 200 and valve body 302 can beformed of hard plastic materials and can be the same or can differrelative to one another. Examples of elastomeric materials that can beutilized include, but are not limited to, polyurethanes,polypropylene-EPDM, other polypropylenes, polysiloxane and/or siliconematerials, butyl materials, isoprenes, neoprenes, polyethylenes andvarious copolymers, composites, blends or other combinations of suchmaterials. Examples of plastics that can be utilized for piston and/orvalve body formation include, but are not limited to, polyethylenes,polypropylenes, polycycloolefines, polyvinyl chlorides (PVC), polyamides(including aliphatic and aromatic variants), polyesters, polycarbonates,polyacrylates, polyurethanes, copolymers, blends, composites andcombinations thereof.

Turning to FIG. 5B, such illustrates over-molded seal 208 a on piston200 supported by projections 223. Also illustrated is channel 220passing longitudinally through the piston and passing through seal 208a. Referring to FIG. 5C, such illustrates over-molded cap 310 on valvebody 302 supported by projections 304 and 306.

Where over-molding is utilized to form pistons and/or valves inaccordance with the invention, the stem/body portions can be fabricatedin a first process and the over-molded seal/cap portion can be formed ina second process. The over-molding will form the seal/cap directly ontothe body or stem portion. The over-molding can occur directly afterformation of the underlying part or the underlying part can be formedinitially and can be removed from the corresponding mold, transferredand/or stored prior to the over-molding process.

The over-molding process can advantageously avoid manual assembly of thepiston or body with respect to the cap or stopper. Additional advantagesof providing an over-molded elastomeric seal include minimization orprevention of fluid leakage between the seal and the underlying piston,and a secure attachment such that the seal does not pull away from theunderlying piston during piston rotation relative to the syringe ordrawing of the piston within the syringe. Additionally, the seal can beconfigured to have a thin wall across the first end of the piston.Relative to conventional piston seals, the thin wall of the over-moldedseal can decrease the piston rebound and thereby minimize the reflux offluid back through the tip of the syringe. Further, the seal can bemolded to have a central protrusion on the front face (not shown)configured to insert at least partially into the fluid passage throughthe syringe tip to further minimize fluid retained in the syringe. Thisfeature can be especially advantageous for administration of costlymedical agents.

Referring to FIG. 6, over-molding can also be utilized in conjunctionwith a multipart piston configuration. In this aspect a piston seal 208can be over-molded onto a piston tip 203 which can be threaded orotherwise attached to alternative piston stems 205, 205′. Stems 205 and205′ and tip 203 can have internal fluid passageways or canalternatively be solid core pieces. Tip 203 can be joined to a pistonstem 205 or 205′ by insertion of an attachment portion of the tip intoan opening 209 of the stem 205 or 205′. In particular configurations thejoining can utilize threading, snap-locking, press-fitting, applicationof an appropriate adhesive or other appropriate joining techniques.

The over-molded seal 208 can be molded to have a diameter ‘d₁’ which canvary depending upon the diameter of the syringe body (not shown) thatwill be utilized. The tip along with the over-molded seal can be joinedwith a piston of an appropriate diameter (e.g. d₂ or d₃) for use withthe particular syringe barrel. Accordingly, a single tip configurationcan be utilized for a wide range of seal, syringe barrel and pistonsizes.

Another embodiment of the invention is described with reference to FIGS.7-9. Referring initially to FIG. 7, piston 200 can include a pistonsleeve 240 and a sleeve insert 230 configured to insert within sleeve240. Sleeve portion 240 can have a seal 208 mounted on first end 202.The seal can have an opening 219 a which passes through the side of theseal and aligns with a similar opening which passes through sleeveportion 240. Sleeve 240 can additionally have a base ring 242 or otherbase structure to allow manipulation of the sleeve.

Sleeve insert 230 can comprise a channel 232 passing from a first end243 of the piston insert along an outside surface of the insert andthrough a collar 234 at opposing end 247 of the insert. A piercingstructure 400 can be provided in association with second end 247 of thepiston insert. Referring to FIG. 8, such shows the detail configurationof an example of a piercing device configuration that can be utilized inassociation with the piston illustrated in FIG. 7.

The piercing structure 400 depicts an illustrative piercing structure inaccordance with the invention. Piercing structure 400 can be describedas having a head segment 401 comprising a tip 402 disposed at a firstend. Piercing structure 400 additionally has a stem/body portion 403which extends from head portion 401 to a base surface 404 disposed at asecond end of the structure opposing the first end. A channel 406 oralternative fluid passageway extends through the base surface andpreferably through an entirety of body portion 403.

Piercing structure 400 can preferably comprise an opening 402 a whichaligns with channel 232 of insert 200 upon seating of the piercingstructure in association with piston 200.

The piercing structure shown in FIG. 8 is an illustrative shape andform. In a preferred aspect of the invention channel 406 extends lessthan an entirety of an internal length of head segment 401 such that thechannel does not pass through tip 402. Rather, one or more access holes408 are provided, for example, through one or both of the externalsurfaces of the head portion. Configurations of the piercing structurewhere the channel does not pass through the tip can advantageouslyminimize or prevent coring of a septum material or plugging of thechannel during a piercing operation. Additional aspects pertaining topiercing structures are set forth in the earlier filed application.

Referring next to FIG. 9, such illustrates the piston device shown inFIG. 7 in an assembled configuration. Sleeve insert 230 is insertedwithin sleeve portion 240. Insert 230 can be rotated relative to sleeveportion 240 to allow the two parts of the device to function as arotatable valve. Typically, first end 202 of the assembled structurewill be inserted within a syringe barrel (not shown). The device caninitially be provided with an accompanying vial such that the vialseptum is intact. In preparation for administration of a medicinalagent, piercing structure 400 can be utilized to pierce the vial septum.Rotation of insert 230 relative to sleeve 240 can be utilized to alignthe fluid channel of the insert with opening 219 a through the pistonseal and the corresponding opening through the piston sleeve. Suchalignment can establish fluid communication between the syringe chamberand the vial. Subsequent combining and mixing of medication componentscan be performed as described above. Upon completion of the mixing, thevalve can be closed by rotation of the insert 230 relative to thesleeve. The administration-ready composition can then be administered orcan be stored prior to administration.

Another mixing and administration system 10 having a multipart piston isdepicted in FIGS. 10-12. Referring initially to FIG. 10, system 10 caninclude a syringe barrel 10 having an internal chamber 102. System 10additionally includes a piston 200 inclusive of a piston sleeve 240 anda sleeve insert 230. Insert 230 can be described as having a stemportion 233, at least a portion of which is hollow to serve as acontainer 255. An insert cap portion 231 can be configured to attach topiston stem 233 thereby covering and enclosing container 255. Anappendage 237 can extend from the piston insert. Appendage 237 cancomprise a stem portion 235 and a disk portion 239 where disk portion239 is configured to fit into a slot on a piston driver of a syringepump.

Sleeve portion 240 can include a piston seal 208. Seal 208 canpreferably be over-molded and can comprise a shape having tapered walls213 that match the internal taper region 103 of syringe chamber 102.

Referring to FIG. 11A, cap portion 231 can be configured to providevalve action utilizing an inserted compression spring 257 and anoverlying retainer 258. Cap 231 and retainer 258 can be formed of hardplastic materials such as those described above. Spring 258 can beformed of an elastomeric material such as those elastomeric materialsset forth above.

Referring next to FIG. 11B, in the illustrated embodiment over-moldedseal 208 can be over-molded onto piston sleeve 240 and also onto cap231. The internal valve spring and the retainer are provided prior tothe over-molding process. Once the over-molding process is complete,stem portion 233 can be positioned by insertion of the stem withinsleeve portion 240. The internal container of insert 233 will typicallycontain a component of a medicinal agent such as, for example, alyophilized powder, at the time of insertion into the sleeve. Cap 231and stem portion 233 can preferably be configured to include a snapfitting, press fitting or other appropriate joining configuration suchthat, once joined, the cap and stem portions do not pull apart upondrawing back of the piston.

FIG. 12 shows an assembled device analogous to the device shown in FIG.10 and having additional optional features. As illustrated, piston 200comprising sleeve 240 and insert 230 is inserted within a syringe barrel100. Sleeve 240 can comprise extension tabs 262 and insert 230 can alsocomprise extension tabs 260. The extension tabs present on the sleeveand the insert can assist in manipulation of the valve associated withthe piston. Squeezing together of the tabs in the A direction can openthe valve. Rotation of the insert relative to the sleeve (direction B)can then be performed to position the tabs to “lock” the sleeve andinsert position relative to one another thereby locking the valve intothe open position. To close the valve the insert can be rotated in anopposing direction and tabs 260 can be moved apart relative to tabs 262.

Preparation of an administration ready agent utilizing the devicedepicted in FIG. 12 can be performed in a manner analogous to thatdescribed above with the exception that the internal container withininsert 230 replaces the earlier described vial. Themixing/administration system 10 shown in FIG. 12 can additionallyinclude an appendage associated with the piston and opposing syringe 100where such appendage is configured to allow insertion into a slot of apiston driver of a syringe pump.

Packaging of the devices of the embodiments described herein can utilizeconventional packaging techniques, or can utilize the packagingtechniques described in the earlier filed application, adapted for thespecific device being packaged.

The features and embodiments described herein can be combined with oneanother where appropriate, and can be utilized in conjunction withfeatures and embodiments disclosed in the earlier filed application. Thefeatures and embodiments of the invention are suitable or adaptable foruse in combination with conventional syringe components, vials, anddevices, as well as those yet to be developed.

In compliance with the statute, the invention has been described inlanguage more or less specific as to structural and methodical features.It is to be understood, however, that the invention is not limited tothe specific features shown and described, since the means hereindisclosed comprise preferred forms of putting the invention into effect.The invention is, therefore, claimed in any of its forms ormodifications within the proper scope of the appended claimsappropriately interpreted in accordance with the doctrine ofequivalents.

1. A syringe device comprising: a syringe barrel; a piston having afirst end insertable within the syringe barrel, a second end opposingthe first end, and an overall length defined between the first an secondends; a vial port disposed within the piston configured to receive avial in lengthwise orientation along a portion of the overall length ofthe piston; and a fluid passageway extending through the piston from thevial port through the first end.
 2. The syringe device of claim 1further comprising a piercing structure disposed in fluid communicationwith the fluid passageway.
 3. The syringe device of claim 1 furthercomprising a valve associated with the fluid passageway.
 4. The syringedevice of claim 1 wherein the vial port is configured to receive a vialthrough an opening along a side of the piston.
 5. The syringe device ofclaim 1 wherein the vial port is configured to receive a vial through anopening in the second end of the piston.
 6. The syringe device of claim1 wherein the piston comprises a hinge, and wherein the vial port isconfigured to receive a vial by inserting the while the hinge is in anopen position and to retain the vial while the hinge is in a closedposition.
 7. The syringe device of claim 1 further comprising a pistonseal disposed at the first end of the piston, the piston seal beingover-molded onto a stem portion of the piston.
 8. A syringe pistoncomprising: a stem portion having one or more projections; and a sealportion over-molded onto the stem portion and covering the one or moreprojections.
 9. The syringe piston of claim 8 further comprising: afluid passageway through at least a portion of a length of the pistonstem; and an opening through the over-molded seal portion.
 10. Thesyringe piston of claim 8 wherein the seal comprises at least one ofcyclic olefin homopolymer materials and cyclic olefin co-polymermaterials.
 11. The syringe piston of claim 8 wherein the stem comprisesa first portion and a second portion, and wherein the seal isover-molded onto the first potion prior to joining the first and secondportions.
 12. The syringe piston of claim 11 wherein the first andsecond stem portions have differing diameters relative to each other.13. A syringe device comprising: a syringe barrel; a syringe pistonhaving a first end insertable within the syringe barrel, and a secondend opposing the first end; a vial housing associated with and extendingfrom the second end of the piston; and a piercing structure associatedwith the second end of the piston and extending into the vial housing.14. The syringe device of claim 13 wherein the vial housing comprises afirst part attached to the second end of the piston and a second partjoinable to the first part.
 15. The syringe device of claim 14 whereinthe first part is attached permanently to the second end of the piston.16. The syringe device of claim 14 wherein the first part is reversiblyattached to the second end of the piston.
 17. The syringe device ofclaim 14 wherein the second part of the housing comprises an appendageconfigured to insert into a slot in a syringe pump.
 18. A syringe devicecomprising: a syringe barrel; a piston sleeve; a sleeve insert having afirst end insertable within the sleeve, an opposing second end, and alength defined by the distance between the first and second ends; afluid channel extending along an exterior side of the sleeve insert fromthe first end at least a portion of the length of the sleeve insert; anda rotary valve controlling fluid communication between the fluid channeland the syringe barrel.
 19. The syringe device of claim 18 wherein therotary valve is configured to establish fluid communication between thesyringe barrel and the fluid channel by rotation of the sleeve insertrelative to the piston sleeve.
 20. The syringe device of claim 18further comprising a vial housing associated with the second end of thesleeve insert.
 21. The syringe device of claim 18 further comprising apiston seal over-molded onto the piston sleeve.
 22. A syringe devicecomprising: a syringe barrel; a piston sleeve; a sleeve insert having afirst end insertable within the sleeve, an opposing second end, and alength defined by the distance between the first and second ends; acompartment disposed within the sleeve insert; and a valve controllingfluid communication between the compartment and the syringe barrel. 23.The syringe device of claim 22 wherein the valve is configured toestablish fluid communication between the syringe barrel and thecompartment by rotation of the sleeve insert relative to the pistonsleeve.
 24. The syringe device of claim 22 wherein the sleeve comprisesan over-molded seal.
 25. The syringe device of claim 22 wherein thesleeve insert comprises a tip portion and a body portion, and furthercomprising a seal over-molded onto the tip potion and onto the pistonsleeve.
 26. The syringe device of claim 25 wherein the body portionirreversibly attaches to the tip portion of the sleeve insert.
 27. Amedication agent preparation system comprising: a syringe comprising: asyringe barrel having an internal chamber; and a piston having a firstend, a second end, and a fluid passageway passing longitudinally throughthe piston, at least a portion of the piston comprising the first endbeing inserted within the chamber; and a valve associated with the fluidpassageway, the valve comprising a valve body and a cap over-molded ontothe valve body.
 28. The system of claim 27 wherein the valve bodycomprises at least one projection, and wherein the at least oneprojection is cover by the over-molded cap.
 29. The system of claim 27wherein the cap comprises an elastomeric material and the valve bodycomprises a hard-plastic material.
 30. The system of claim 27 furthercomprising: a piercing structure associated with the second end of thepiston, and comprising a fluid channel and a tip; a vial disposedproximate the piercing structure; a first component of a medicationagent disposed within the internal chamber; and a second component ofthe medication agent disposed within the vial.
 31. The system of claim30 wherein the valve selectively isolates the first component from thesecond component.
 32. A method of preparing a medication agent foradministration to an individual, comprising: providing a syringecomprising a syringe barrel and a piston disposed at an initial positionrelative to the syringe barrel, the piston comprising a piston sleeveand a sleeve insert; providing a first component within the syringebarrel; providing a second component within a vial; providing a valveassociated with a fluid passageway between the vial and the syringebarrel, the valve being initially provided in a closed position,blocking fluid passage through the passageway; repositioning the valve;sliding the piston to join the first component with the secondcomponent; mixing the first and second component to form a medicationagent; and drawing the medication agent into the syringe barrel.
 33. Themethod of claim 32 wherein the valve is a rotary valve actuated byrotation of the piston sleeve relative to the sleeve insert.
 34. Themethod of claim 32 wherein the fluid passageway comprises a channeldisposed along a sidewall surface of the sleeve insert.
 35. The methodof claim 34 wherein the piston further comprises a seal over-molded ontothe piston sleeve, the seal having an opening alignable with the channelby rotation of the sleeve insert relative to the piston sleeve.
 36. Themethod of claim 32 further comprising: providing a piercing structureassociated with the piston insert; and prior to repositioning the valve,utilizing the piercing structure to pierce a septum comprised by thevial.
 37. A method of preparing a composition comprising; providing asyringe barrel having a barrel chamber containing a first component;providing a piston having a compartment containing a second component,the piston comprising: a piston sleeve; a sleeve insert comprising a tipand a body; and a seal over-molded onto the tip and an end of the pistonsleeve, the seal having at least one opening passing therethrough;rotating the piston sleeve relative to the insert to establish fluidcommunication between the compartment and the barrel chamber; slidingthe piston to join the first and second components; mixing the first andsecond components to form a composition; and drawing the compositioninto the syringe chamber.
 38. The method of claim 37 wherein the firstcomponent comprises a liquid.
 39. The method of claim 37 wherein thesecond component comprises a lyophilized substance.
 40. The method ofclaim 37 wherein sleeve insert further comprises an appendage configuredfor insertion into a slot in a syringe pump.
 41. The method of claim 37wherein the tip is permanently attached to the body of the sleeveinsert.
 42. The method of claim 37 wherein the seal comprises anelastomeric material.